NCT00168727

Brief Summary

The purpose of this study is to determine the safety and effectiveness of a treatment regimen using Zevalin® plus Rituxan® for patients who have low grade Non-Hodgkin's Lymphoma (NHL) or relapsed Non-Hodgkin's lymphoma and have been previously treated. This study will use an experimental scheduling regimen. No chemotherapy will be used in this study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2003

Typical duration for phase_4

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2005

Completed
Last Updated

August 23, 2023

Status Verified

August 1, 2023

First QC Date

September 13, 2005

Last Update Submit

August 21, 2023

Conditions

Lymphoma, Non-HodgkinLymphoma, Low-Grade

Keywords

RadioimmunotherapyAntigens, CD20

Outcome Measures

Primary Outcomes (1)

  • Determine overall response rate, event-free survival, time-to-progression, time-to-next-therapy, and freedom-from-relapse in pts with low-grade lymphoma in first or second relapse treated with Zevalin® followed by 2 yrs of Rituxan maintenance therapy

Secondary Outcomes (1)

  • Evaluate relative response rates in populations with and without prior rituximab therapy, in first versus second relapse, and with and without bulky (> 5 cm in greatest diameter) disease.

Interventions

ibritumomab tiuxetan (Zevalin®)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Follicular non-Hodgkin's lymphoma including SLL in first or second relapse.
  • No anticancer therapy for three wks (six wks if nitrosourea or Mitomycin C); not rituximab refractory.
  • Age \>= 18 years, not pregnant or lactating.
  • Expected survival \>= 3 mths; PS 0, 1, or 2.
  • ANC \>= 1,500/mm3, platelet counts \>= 100,000/mm3.
  • Total bilirubin \> 2.0 mg/dL, creatinine \> 2.0 mg/dL.
  • Total lymphocyte count \< 5,000/mm3 for SLL.
  • \<25% bone marrow involvement with lymphoma.

You may not qualify if:

  • Prior ABMT or ASCT, hypocellular or marked reduction in bone marrow precursors, or history of failed stem cell collection.
  • Bulky areas of disease more than 10 cm in diameter.
  • Patients with CLL, CNS, or mantle cell lymphoma.
  • Hx of HIV/AIDS related lymphoma, hepatitis B or C.
  • Prior radioimmunotherapy or XRT to \>25% of active bone marrow.
  • G-CSF or GM-CSF within 2 wks, pegylated G-CSF within 4 wks of treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Loma Linda University

Loma Linda, California, United States

Location

North County Oncology

Oceanside, California, United States

Location

Medical Specialists of Fairfield

Fairfield, Connecticut, United States

Location

Queens Hospital

Honolulu, Hawaii, United States

Location

Northwest Oncology and Hematology

Elk Grove Village, Illinois, United States

Location

Horizon Oncolgy Center

Lafayette, Indiana, United States

Location

Specialists in Hematology/Oncology

St Louis, Missouri, United States

Location

Presbyterian Hospital Cancer Center

Charlotte, North Carolina, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

ibritumomab tiuxetan

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Wayne Saville

    Biogen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

June 1, 2003

Study Completion

October 31, 2005

Last Updated

August 23, 2023

Record last verified: 2023-08

Locations

US(8)